national veterinary services laboratories fm-nahln-0023.03 … · 2019-04-02 · national...

2
National Veterinary Services Laboratories FM-NAHLN-0023.03 Page 2 of 3 REQUEST TO DEVIATE FROM A NAHLN DOCUMENT USDA, APHIS, VS recognizes that NAHLN laboratories may be requested to deviate from a NAHLN testing standard operating procedure or other NAHLN document. NAHLN Laboratories must submit this completed form to the NAHLN Program Office for approval prior to deviating from the approved use of NAHLN assays. The completed form must be scanned and e-mailed to: [email protected]. Submitted forms will be reviewed, and the submitting NAHLN Laboratory will receive the signed document (approved or denied) by e-mail. A. Laboratory Name: Laboratory Director: Laboratory Director’s Telephone number: Laboratory Director’s e-mail Address B. Date range of planned event (or period of time deviation will be performed): NAHLN SOP & Version Number (one per form): NAHLN SOP Name: C. Description of the proposed planned deviation: D. Technical justification for the proposed planned deviation: By signing this form the Laboratory Director is: Requesting a planned deviation from the listed NAHLN Document. Understands the reporting requirements associated with conducting tests off-protocol and will report to the client that the test used was not validated for the specific deviation. Understands that no deviations are allowed without approval from NVSL. Failure to comply with all regulations and policies by any party may result in immediate loss of the laboratory’s approval to conduct NAHLN testing. Understands that this deviation, if approved, will expire upon the release date of a new NAHLN SOP version. It is the requesting laboratory’s responsibility to renew the request to deviate if still needed.

Upload: others

Post on 17-Jun-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: National Veterinary Services Laboratories FM-NAHLN-0023.03 … · 2019-04-02 · National Veterinary Services Laboratories FM-NAHLN-0023.03 Page 2 of 3 REQUEST TO DEVIATE FROM A NAHLN

National Veterinary Services Laboratories

FM-NAHLN-0023.03

Page 2 of 3

REQUEST TO DEVIATE FROM A NAHLN DOCUMENT

USDA, APHIS, VS recognizes that NAHLN laboratories may be requested to deviate from a NAHLN testing standard operating procedure or other NAHLN document. NAHLN Laboratories must submit this completed form to the NAHLN Program Office for approval prior to deviating from the approved use of NAHLN assays.

The completed form must be scanned and e-mailed to: [email protected].

Submitted forms will be reviewed, and the submitting NAHLN Laboratory will receive the signed document (approved or denied) by e-mail.

A. Laboratory Name:

Laboratory Director:

Laboratory Director’s Telephone number:

Laboratory Director’s e-mail Address

B. Date range of planned event (or period of time deviation will be performed):

NAHLN SOP & Version Number (one per form):

NAHLN SOP Name:

C. Description of the proposed planned deviation:

D. Technical justification for the proposed planned deviation:

By signing this form the Laboratory Director is: Requesting a planned deviation from the listed NAHLN Document. Understands the reporting requirements associated with conducting tests off-protocol and will report to the

client that the test used was not validated for the specific deviation. Understands that no deviations are allowed without approval from NVSL. Failure to comply with all

regulations and policies by any party may result in immediate loss of the laboratory’s approval toconduct NAHLN testing.

Understands that this deviation, if approved, will expire upon the release date of a new NAHLN SOP version.It is the requesting laboratory’s responsibility to renew the request to deviate if still needed.

Page 2: National Veterinary Services Laboratories FM-NAHLN-0023.03 … · 2019-04-02 · National Veterinary Services Laboratories FM-NAHLN-0023.03 Page 2 of 3 REQUEST TO DEVIATE FROM A NAHLN

National Veterinary Services Laboratories

FM-NAHLN-0023.03

Page 3 of 3

E. Laboratory

Director’s Review

Signature and date

F. NVSL & NAHLN Review

NVSL Reference Laboratory:

Deviation Approved

Deviation Denied

Justification:

Signature and date

NAHLN Coordinator/ designee:

Deviation Approved

Deviation Denied

Justification:

Signature and date